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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Cranial
510(k) Number K001167
Device Name OPI BAND
Applicant
Orthomerica Products, Inc.
1001 Pennsylvania Ave. Nw.
6th Floor
Washington,  DC  20004
Applicant Contact WILLIAM H.E. VON OEHSEN
Correspondent
Orthomerica Products, Inc.
1001 Pennsylvania Ave. Nw.
6th Floor
Washington,  DC  20004
Correspondent Contact WILLIAM H.E. VON OEHSEN
Regulation Number882.5970
Classification Product Code
MVA  
Date Received04/10/2000
Decision Date 07/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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